The European Federation of Pharmaceutical Industries and Associations (EFPIA) has elected a new president and vice presidents who have set out a key priority for their term: a series of amendments to the proposed European Commission (EC) pharmaceutical legislation reform, which the organisation has warned will further accelerate the loss of Europe’s competitiveness.
We look forward to working with policymakers across Europe to reach a shared understanding of how we can best achieve our goals for competitiveness and health, together
Lars Fruergaard Jørgensen, President, EFPIA
The EFPIA’s newly elected presidency team, composed of Novo Nordisk CEO Lars Fruergaard Jørgensen as president, Bayer pharma division head Stefan Oelrich as first VP and Ipsen CEO David Loew as second VP, recently restated the organisation’s concerns about the impact of the EC’s proposed pharmaceutical legislation overhaul.
The organisation’s new president and vice presidents feel the proposed legislation in its current form will further damage Europe’s waning competitive capacity, a trend it demonstrates through the 25 percent relative decline in European R&D as well as other figures published in an annual overview of the industry.
The new presidency team set forth focus areas in which it urges for amendments to the EC’s draft proposal, claiming that the EFPIA and its members remain committed to working with policymakers to achieve shared goals. “We need to work in partnership to innovate new medicines that change people’s lives, improve the effectiveness of health systems, and benefit society as a whole,” said Fruergaard Jørgensen. “We look forward to working with policymakers across Europe to reach a shared understanding of how we can best achieve our goals for competitiveness and health, together.”
“The data is showing us that we are losing ground to the US and Asia and companies have given numerous warnings that the proposals will exacerbate this trend. If we are to realise the ambition of the legislation – to boost research and innovation and to improve healthcare for patients across the EU – we must work together and agree on a vision that works for patients, health systems and the future of European science,” EFPIA Director General Nathalie Moll maintained.
Regulatory Impact: Yes but …
The proposed legislation looks to modernise Europe’s regulatory system and the measures it foresees are set to speed up the regulatory process from 400 to 180 days while further updating it through digitalisation and use of real-world evidence and data.
The EFPIA sees these updates, which should expedite access and produce savings for innovators, as positive and sorely needed developments in light of the fact that drug approvals in the EU have become slower than the US and other regions. However, the new presidency team believes the European regulatory framework needs to be “further optimised” and includes this in its list of issues for proposed revision.
Reduced Incentives: The Sore Point for Innovators
The real bone of contention for the EFPIA and its members as represented by the newly elected team is the proposed reduction of the Regulatory Data Protection (RDP) period. The current standard has been reduced from eight to six years, meaning pharma companies would have a baseline period of regulatory protection of six years plus the customary two years of market protection, adding up to a total of eight years instead of the current ten. In some exceptional cases innovators would be able to benefit from additional RDP periods with regulatory protection for Orphan Medicinal Products (OMPs) going up to 13 years compared to 10 years today.
The new EFPIA presidency says it wants to amend this point to “strengthen, rather than cut, the region’s RDP baseline and orphan drug market exclusivity,” arguing that the proposed legislation “significantly reduces European intellectual property (IP) rights while adding complex incentives for additional IP protection which in practice makes it impossible to achieve these incentives.” This in turn, they argue, will lead to reduced investments in R&D, thus further undermining Europe’s competitiveness.
The EFPIA’s statement asserted that over the coming months the organisation will remain “committed to working with Members of the European Parliament (MEPs), Member States and other stakeholders to close, rather than widen, the gap between the EU and the US and Asia.”
Photo Source: Nathalie Moll on LinkedIn